Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea

Browse trials for

• Diarrhea 852

Keywords

• symptomatic treatment of patients with refractory diarrhea

Diarrhea

852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.

This study's enrollment of 42 is below the median of 136 across 713 interventional studies indexed under Diarrhea.

Lead sponsor

Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Study arms

• Experimental
  lanreotide (Autogel formulation) Autogel 120mg

  lanreotide (Autogel formulation) Autogel 120mg

  Drug: lanreotide (Autogel formulation)

Interventions

• Druglanreotide (Autogel formulation)

  Autogel 120mg

Primary outcomes

1. Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/24hours) in the Mean Number of Stools (Mean of Last 7 Days)

   Time frame: Day 28

Secondary outcomes

1. Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline

   SF36 QOL includes 1 multi-item scale measuring each of 8 health concepts. These scores are summed to produce raw scale scores for each health concept which are transformed to a 0-100 scale. The lower the score the more disability. The higher the score the less disability. There is in addition a single-item measure of Health Transition IBS-QOL is a self-report QOL measure specific to IBS that can be used to assess impact of IBS and its treatment. This consists of 34 items,each with a 5 point response scale.Individual responses to 34 items are summed and averaged for a total score and transformed to a 0-100 scale with higher scores indicating better IBS specific QOL

   Time frame: Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56

2. Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline

   Each patient scored his/her stool on the Bristol Stool Form Scale: Type 1 - Separate hard lumps, like nuts (hard to pass); Type 2 - Sausage-shaped but lumpy; Type 3 - Like a sausage but with cracks on its surface; Type 4 - Like a sausage or snake, smooth and soft; Type 5 - Soft blobs with clear-cut edges (passed easily); Type 6 - Fluffy pieces with ragged edges, a mushy stool; Type 7 - Water no solid pieces, Entirely liquid

   Time frame: Baseline (day 1), day 28 and day 56

3. Percent Change in Mean Number of Stools Compared to Baseline

   Time frame: Baseline (Day 1), Day 28 and Day 56

4. Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects

   Normalization of stool frequency in subjects with refractory diarrhoea at Day 28 and Day 56 (mean of last 7 days) compared to Baseline.

   Time frame: Baseline (Day 1), Day 28 and Day 56

5. Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools

   Time frame: Day 56

Baseline characteristics

Publications

• Bisschops R, De Ruyter V, Demolin G, Baert D, Moreels T, Pattyn P, Verhelst H, Lepoutre L, Arts J, Caenepeel P, Ooghe P, Codden T, Maisonobe P, Petrens E, Tack J. Lanreotide Autogel in the Treatment of Idiopathic Refractory Diarrhea: Results of an Exploratory, Controlled, Before and After, Open-label, Multicenter, Prospective Clinical Trial. Clin Ther. 2016 Aug;38(8):1902-1911.e2. doi: 10.1016/j.clinthera.2016.06.012. Epub 2016 Aug 8. PubMed 27423779 ↗